Healthcare Industry News: liver failure
News Release - May 14, 2021
FDA Responds to Creative Medical Technology Holdings Regarding Its ImmCelz(R) IND for Stroke TreatmentFDA Responds to Company's IND #27375 Including Pharmacology, Manufacturing and Clinical Sections
PHOENIX, May 14, 2021 -- (Healthcare Sales & Marketing Network) -- Creative Medical Technology Holdings Inc., trading under ticker symbol CELZ, announced today receipt of detailed correspondence from the FDA regarding necessary modifications to IND #27375 for using ImmCelz® regenerative immunotherapy for the treatment of stroke.
The Company's ImmCelz® product utilizes a patient's own blood cells that have been "reprogrammed" in the laboratory by culturing with established universal donor stem cells, followed by re-infusion into the patient. Efficacy in animal models has been demonstrated in heart failure, kidney failure, multiple sclerosis, liver failure and type 1 diabetes. Given that this is the first time such a product was brought to the FDA, the Company appreciates the detailed analysis provided by the Agency, and the constructive feedback.
"I am grateful for our scientific and clinical team which has assembled the ImmCelz® IND proposal for the FDA, which resulted in detailed comments and advice for moving forward. Our team is already working on it." said Timothy Warbington, President and CEO.
About Creative Medical Technology Holdings
Creative Medical Technology Holdings, Inc. is a commercial stage biotechnology company specializing in regenerative medicine/stem cell technology in the fields of immunotherapy, urology, neurology and orthopedics and is listed on the OTC under the ticker symbol CELZ. For further information about the company, please visit www.creativemedicaltechnology.com.
Forward Looking Statements
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Source: Creative Medical Technology
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